LOW LOAD RESISTANCE BLOOD FLOW RESTRICTION TRAINING VERSUS NEUROMUSCULAR TRAINING IN KNEE OSTEOARTHRITIS
Primary Purpose
Osteoarthritis of the Knee
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Traditional exercise therapy
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring Blood flow restriction training
Eligibility Criteria
Inclusion Criteria:
- Age range from 45-60 years (Segal et al., 2015).
- Walk with painful knee OA without assistive devices (Bryk et al., 2016).
- Mild to moderate unilateral OA grade II-III (K/L) (Bryk et al., 2016).
- BMI < 30 kg/m² (not being classified as obese) (Bryk et al., 2016).
- Never participated in resistance training in the 3 months prior to their appointment (Jan et al., 2008)
Exclusion Criteria:
- Severe knee OA (grade IV according to K/L classification).
- Bilateral knee OA.
- Congenital or acquired inflammatory, rheumatic or neurological (systemic or local) diseases involving the knee.
- Repeated treatment with steroids.
- Secondary knee OA.
- Received joint replacement surgery in either Knee or/and hip.
- Cardiovascular and neuromuscular disorders
- Diabetic patients
- Psychiatric disorders.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
control group (Traditional therapy group)
Experimental group I (BFR training group)
Experimental group II (Neuromuscular training group)
Arm Description
control group (Traditional therapy group) (n=21): patients will receive traditional training exercises (high load resistance training
Experimental group I (BFR training group) (n=21): patients will receive LLRT with BFR.
Experimental group II (Neuromuscular training group) (n=21): patients will receive neuromuscular training exercises
Outcomes
Primary Outcome Measures
Muscle strength
Hand-Held Dynamometer for measuring muscle strength
Secondary Outcome Measures
Knee joint function
Western Ontario and McMaster Universities osteoarthritis index for an Arab population for assessing knee function
Full Information
NCT ID
NCT04600661
First Posted
October 19, 2020
Last Updated
October 19, 2020
Sponsor
Mai Mohamed Abdelkader Abdallah
1. Study Identification
Unique Protocol Identification Number
NCT04600661
Brief Title
LOW LOAD RESISTANCE BLOOD FLOW RESTRICTION TRAINING VERSUS NEUROMUSCULAR TRAINING IN KNEE OSTEOARTHRITIS
Official Title
LOW LOAD RESISTANCE BLOOD FLOW RESTRICTION TRAINING VERSUS NEUROMUSCULAR TRAINING IN KNEE OSTEOARTHRITIS
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2021 (Anticipated)
Primary Completion Date
June 15, 2021 (Anticipated)
Study Completion Date
September 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mai Mohamed Abdelkader Abdallah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study will be conducted to compare the effect of BFR with LLRT versus neuromuscular training on quadriceps muscle strength, knee joint function and proprioception accuracy.
Detailed Description
PURPOSE:
This study will be conducted to compare the effect of BFR with LLRT versus neuromuscular training on quadriceps muscle strength, knee joint function and proprioception accuracy.
BACKGROUND:
Patients with knee OA may have reduction of tolerance of the high-load programs which is recommended for eliciting strength gains (Messier et al., 2013). Thus, for reducing disease risk and enhancing physical function, there is a need for effectively strengthening the quadriceps muscle while limiting pain and adverse joint loading in people with knee OA (Segal et al., 2015). Blood flow restriction (BFR) with low-load resistance training (LLRT) is an alternative to traditional strength training that can be used in knee OA with minimal adverse joint loading that is normally found in traditional strengthening programs(Pope et al., 2013). It is attained through applying pressure externally with a pneumatic cuff or tourniquet. The applied pressure occludes venous outflow while maintaining arterial inflow with intent to promote blood pooling in the capillary beds of the limb muscles distal to the tourniquet (Slysz et al., 2016). Kubota et al., (2008), showed that BFR can be applied during periods of immobilization to decrease disuse muscle atrophy of limbs. Also it can be combined with exercise which enhances muscular development. Resistance exercise appears to provide great muscular gains when combined with BFR (Slysz et al., 2016).
HYPOTHESES:
There will not be a significant difference between traditional training, BFR with LLRT and neuromuscular training on improving quadriceps muscle strength using HHD in patients with unilateral knee OA.
There will not be a significant difference between traditional training, BFR with LLRT and neuromuscular training on improving knee joint function on WOMAC questionnaire in patients with unilateral knee OA.
There will not be a significant difference between traditional training, BFR with LLRT and neuromuscular training on improving knee joint proprioception in patients with unilateral knee OA.
RESEARCH QUESTION:
Does blood flow restriction with low load resistance training and neuromuscular training have a significant effect over traditional rehabilitation protocol (stretching and strengthening for hip and knee muscles) on quadriceps muscle strength, knee joint function and proprioception accuracy in patients with unilateral knee OA?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
Blood flow restriction training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Sixty Three patients of both genders with mild to moderate unilateral tibiofemoral OA, with age range from 45-60 years will be randomly assigned to 1 of 3 groups control group (Traditional therapy group) (n=21): patients will receive traditional training exercises (high load resistance training) Experimental group I (BFR training group) (n=21): patients will receive LLRT with BFR.
Experimental group II (Neuromuscular training group) (n=21): patients will receive neuromuscular training exercises
Masking
InvestigatorOutcomes Assessor
Masking Description
Sixty Three patients of both genders with mild to moderate unilateral tibiofemoral OA, with age range from 45-60 years will be randomly assigned to 1 of 3 groups using opaque, sealed envelopes, each containing the name of one of the groups. Each patient will sign an informed consent before starting the study (Appendix III). All patients will be referred by the orthopedic surgeon who will diagnose knee OA based on clinical and radiological examination. The investigator will be blinded
Allocation
Randomized
Enrollment
63 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group (Traditional therapy group)
Arm Type
Experimental
Arm Description
control group (Traditional therapy group) (n=21): patients will receive traditional training exercises (high load resistance training
Arm Title
Experimental group I (BFR training group)
Arm Type
Experimental
Arm Description
Experimental group I (BFR training group) (n=21): patients will receive LLRT with BFR.
Arm Title
Experimental group II (Neuromuscular training group)
Arm Type
Experimental
Arm Description
Experimental group II (Neuromuscular training group) (n=21): patients will receive neuromuscular training exercises
Intervention Type
Other
Intervention Name(s)
Traditional exercise therapy
Other Intervention Name(s)
Blood flow restriction training
Intervention Description
Neuromuscular training
Primary Outcome Measure Information:
Title
Muscle strength
Description
Hand-Held Dynamometer for measuring muscle strength
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Knee joint function
Description
Western Ontario and McMaster Universities osteoarthritis index for an Arab population for assessing knee function
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age range from 45-60 years (Segal et al., 2015).
Walk with painful knee OA without assistive devices (Bryk et al., 2016).
Mild to moderate unilateral OA grade II-III (K/L) (Bryk et al., 2016).
BMI < 30 kg/m² (not being classified as obese) (Bryk et al., 2016).
Never participated in resistance training in the 3 months prior to their appointment (Jan et al., 2008)
Exclusion Criteria:
Severe knee OA (grade IV according to K/L classification).
Bilateral knee OA.
Congenital or acquired inflammatory, rheumatic or neurological (systemic or local) diseases involving the knee.
Repeated treatment with steroids.
Secondary knee OA.
Received joint replacement surgery in either Knee or/and hip.
Cardiovascular and neuromuscular disorders
Diabetic patients
Psychiatric disorders.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mai M Abdelkader
Phone
+201094355573
Email
mai.abdelkader@pua.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Enas Fawzy, Prof
Phone
+2 01127867507
Email
Enas.fawzy@pt.cu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26971109
Citation
Bryk FF, Dos Reis AC, Fingerhut D, Araujo T, Schutzer M, Cury Rde P, Duarte A Jr, Fukuda TY. Exercises with partial vascular occlusion in patients with knee osteoarthritis: a randomized clinical trial. Knee Surg Sports Traumatol Arthrosc. 2016 May;24(5):1580-6. doi: 10.1007/s00167-016-4064-7. Epub 2016 Mar 12.
Results Reference
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LOW LOAD RESISTANCE BLOOD FLOW RESTRICTION TRAINING VERSUS NEUROMUSCULAR TRAINING IN KNEE OSTEOARTHRITIS
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